MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. FISHER-SURE-VUE HCG-STAT SRM/URINE (30T); PREGNANCY TEST

Model Number FHC-A202

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Results pending investigation.

Event Description

(b)(6) 2019: patient presented to the facility for a laparoscopic bilateral salpingectomy.Patient urine was tested on the fisher sure-vue hcg stat serum/urine kit by a new technician and at 3 minutes, a negative result was obtained.The technician took a second look at the cassette before the 4 minute read time and the technician observed a faint positive result.The technician retested the urine sample under the supervision of an experienced technician and a positive result was obtained at 3 minutes.The surgery was delayed based on the false positive result.A quantitative serum hcg test was performed and the result was negative at <1.2 miu/ml.The customer was unable to state how long the surgery was delayed, however, she believes the surgery was performed the same day.The procedure was not emergent; it was a scheduled procedure.No adverse patient outcomes reported.Troubleshooting was performed focusing on possible causes such as deviations in storage, technique, handling and patient specimen factors as specified in the corresponding package insert.

Manufacturer Narrative

Additional information: update to d4: udi added.Update to d10: device available for evaluation changed to yes.Update to h3: changed to yes.Update to h6: method code 11 and 4101 added.Result code 213 added.Conclusion code 67 added.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative urine samples and low concentration standards.The results were read at 3 and 4 minutes, and all devices yielded the expected negative results.Due to the limited number of devices available, returned product was tested only with hcg-negative urine samples.The results were read at 3 and 4 minutes, and all devices yielded the expected negative results.No false positive results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information, as the reported issue was not replicated during testing of either retention or returned product.Case details indicate that the patient was taking bupropion and citalopram at the time of testing.Per the package insert, these medications are not among the compounds that have been tested for interference with this assay.For more information, see the interfering substances section of the package insert.Per the package insert, this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

• Brand Name: FISHER-SURE-VUE HCG-STAT SRM/URINE (30T)
• Type of Device: PREGNANCY TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• MDR Report Key: 9500817
• MDR Text Key: 189218256
• Report Number: 2027969-2019-00616
• Device Sequence Number: 1
• Product Code: JHI
• Combination Product (y/n): N
• PMA/PMN Number: K062361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: FHC-A202
• Device Lot Number: HCG9050160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BUPROPION(UNSPECIFIED DOSE); CITALOPRAM(UNSPECIFIED DOSE)
• Patient Age: 24 YR
• Patient Weight: 108